Identifying symptoms of premenstrual syndrome and premenstrual dysphoria

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to identify and describe the symptoms associated with premenstrual syndrome (PMS) in women. Participants will undergo clinical interviews, self-rating scales, and evaluations of mood and endocrine function. A subgroup of women with severe PMS, known as Premenstrual Dysphoric Disorder (PMDD), will be invited to participate in additional studies focusing on endocrine changes, treatment evaluations, and genetic factors. The study also includes women with recurrent brief depression as a comparison group.

Why it matters

Who can join: the full rules

* INCLUSION CRITERIA:

The subjects of this study will be women who meet the following criteria:

* history within the last two years of at least six months with menstrually-related mood or behavioral disturbances of at least moderate severity - that is, disturbances that are distinct in appearance and associated with a notable degree of subjective distress;
* a 30% increase in mean negative mood ratings (relative to the range of the scale employed) in the premenstrual week compared with the week following the end of menses in at least two of three cycles;
* age 18 to 50;
* not pregnant and in good medical health;
* regular menses.

For subjects with recurrent brief depression:

* dysphoric mood or loss of interest or pleasure;
* duration less than two weeks;
* four of the following symptoms: poor appetite or significant weight loss (when not dieting) or increased appetite or significant weight gain; insomnia or hypersomnia; psychomotor agitation or retardation; loss of interest or pleasure in usual activities, or decrease in sexual drive; loss of energy; fatigue; feelings of worthlessness, self-reproach, or excessive or inappropriate guilt; diminished ability to think or concentrate, slowed thinking, or indecisiveness;
* impairment in usual occupational activities;
* at least one-two episodes per month over one year.

Age-matched women without mood and behavioral disorders will be recruited.

EXCLUSION CRITERIA for all study participants:

* Subjects should have no general medical illness that is primary (i.e., appears to be causing the mood disorder);
* Current antidepressant therapy (since this is a screening protocol for subsequent treatment and physiologic evaluation studies in which participants must be untreated). Antidepressants will not be withheld from participants who need or want them;
* Current alcohol or substance use or dependence (excluding nicotine) of sufficient magnitude to require independent, concurrent treatment intervention (e.g., antabuse or opiate treatment, but not including self-help groups).
* Pregnant or lactating women
* Subjects who are unable to provide informed consent
* NIMH employees/staff and their immediate family members will be excluded from the study per NIMH policy.

Where it's running

• National Institutes of Health Clinical Center
  Bethesda, Maryland, United States Recruiting

Study contacts

• Principal investigator: Peter J Schmidt, M.D. — National Institute of Mental Health (NIMH)
• Study coordinator: Peter J Schmidt, M.D.
• Email: peterschmidt@mail.nih.gov
• Phone: (301) 496-6120

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.